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CENTER FOR DRUG EVALUATION AND RESEARCH
ADVANCING HEALTH
THROUGH INNOVATION
2018 NEW DRUG
THERAPY APPROVALS
Impact | Innovation | Predictability | Access
January 2019
January 2019
2
Table of Contents
Introduction 3
2018: Another Strong Year for Innovation and Advances 4
Novel Drugs 7
Impact of Novel Drug Approvals 9
Innovation: Frequent Use of Expedited Development and Review Pathways 18
Predictability: Meeting PDUFA Goals 20
Access: First Cycle Approval and Approvals Compared to Other Countries 21
New and Expanded Uses of Already FDA-Approved Drugs 22
New Uses 22
New Populations 25
Additional Approvals 26
Biosimilars 26
New Formulations and Other Notable Approvals 28
New Dosage Forms 30
Conclusion 31
Appendix A: Drug Designation Summary 32
Appendix B: Novel Drug Designation Summary 34
Advancing Health Through Innovation
3
Introduction
Welcome to the FDA’s Center for Drug Evaluation and Research’s (CDER)
annual report, Advancing Health Through Innovation: New Drug Ther
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